RecruitingPhase 2NCT06399406

Mindfulness Engaged Neurostimulation for Depression


Sponsor

University of California, San Diego

Enrollment

70 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining mindfulness-based therapy with transcranial magnetic stimulation (TMS — a non-invasive brain stimulation technique) can help people with treatment-resistant depression. It targets people who haven't responded well to antidepressant medications. **You may be eligible if...** - You have been diagnosed with major depressive disorder (not bipolar) - At least one antidepressant medication has not worked for you - Your depression is rated moderate to severe on a standard scale - You have not started or changed antidepressants in the last 4 weeks **You may NOT be eligible if...** - You have a neurological condition or history of seizures - You are medically unstable - You are currently showing active suicidal behavior - You are pregnant or breastfeeding - You have a psychotic disorder or active psychotic symptoms - You have a metal implant in your head or another device that is unsafe for TMS - You cannot have an MRI scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMedi-TBS

The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.


Locations(1)

University of California San Diego

La Jolla, California, United States

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NCT06399406


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